Pivotal 1 Study of ABBV-RGX-314 (Also Known as RGX-314) Gene Therapy Administered Via Subretinal Delivery One Time in Participants With nAMD

Prior treatment

• History of intraocular surgery in the study eye within 12 weeks prior to randomization
• History of intravitreal therapy in the study eye, such as intravitreal steroid injection or investigational product, other than anti-VEGF therapy, in the 6 months prior to Screening Visit 1
• Prior treatment with gene therapy
• History of intraocular surgery in either eye within 12 weeks prior to randomization (Week -2)
• History of intravitreal therapy in either eye, such as intravitreal steroid injection or investigational product, other than anti-VEGF therapy, in the 6 months prior to screening
• Prior treatment with gene therapy (\*) For previously treated crossover participants, criteria apply to the eye not treated in the main study only.

Other illness

• Any condition in the investigator's opinion that could limit VA improvement in the study eye
• Active or history of retinal detachment, or current retinal tear that cannot be treated, in the study eye
• Advanced glaucoma or history of secondary glaucoma in the study eye
• Recent myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months
• Any condition in the investigator's opinion that could limit VA improvement in either eye
• Active or history of retinal detachment, or current retinal tear that cannot be treated in either eye
• Advanced glaucoma or history of secondary glaucoma in either eye
• Myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months

Other

• CNV or macular edema in the study eye secondary to any causes other than AMD
• Subfoveal fibrosis or atrophy in the study eye, as determined by CRC
• CNV or macular edema in either eye secondary to any causes other than AMD
• Subfoveal fibrosis or atrophy in either eye

• Age ≥ 50 years and ≤ 89 years
• An ETDRS BCVA letter score between ≤ 78 and ≥ 40 in the study eye
• Diagnosis of subfoveal CNV secondary to AMD in the study eye previously treated with anti-VEGF
• Must be pseudophakic (at least 12 weeks postcataract surgery) in the study eye.
• Willing and able to provide written, signed informed consent for this study
• Participants must have demonstrated a meaningful response to anti-VEGF therapy at study entry
• An ETDRS BCVA letter score between ≤ 83 and ≥ 40 in both eyes
• Diagnosis of subfoveal choroidal neovascularization (CNV) secondary to AMD in both eyes
• Must be pseudophakic (at least 12 weeks postcataract surgery) in both eyes
• Willing and able to provide written, signed informed consent for this study
• Newcomers must have active disease in the study eye; crossover participants must have active disease in the eye not treated in the main study